The Effect of Therapeutic Hypothermia on Deceased Donor Renal Graft Outcomes - a Randomized Controlled Trial From the Region 5 Donor Management Goals Workgroup
NCT ID: NCT01680744
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
370 participants
INTERVENTIONAL
2012-05-31
2014-11-30
Brief Summary
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Detailed Description
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To alleviate the aforementioned supply-demand imbalance, there are two major unmet needs that must be urgently addressed. First, active medical interventions that are tested prospectively to protect the organ during the donation process hold sizable potential, but remain exceedingly rare. Second, compliance with pre-defined donor management protocols to restore and stabilize deceased organ donor physiologic functions remains low across different donation service areas, despite evidence that these protocols may improve organ yield.
The goal of this proposal, therefore, is to demonstrate that (1) therapeutic hypothermia as an active medical intervention for the DNDD donor and (2) compliance with donor management protocols can substantially improve allograft function and survival.
The investigators will accomplish this goal by extending an existing research infrastructure (HRSA, R380T10586) across several donor service areas. As such, the investigators will bring together a research network and use the power of this network to properly test a simple medical intervention, therapeutic hypothermia for renal protection, in a prospective randomized single blinded trial. Therapeutic hypothermia is an established cytoprotective intervention that has been demonstrated to be highly protective of organs in select critically ill patients. By combining two of the largest donation service areas in the nation (CTDN, Northern California and OneLegacy, Southern California), the investigators will have access to approximately 10% of all organ donors in the nation. This proposal aims to randomize 500 DNDD organ donors, the biggest cohort enrolled in a prospective randomized trial.
The investigators will further leverage this network to track trial specific donor management protocols variables goals and drive tighter compliance with already established donor management protocols across all donor service areas in Region 5. This will allow the investigators to compile a large historical control cohort that will facilitate answering additional research questions with great detail. All organ procurement areas in Region 5 have confirmed their willingness to participate in this effort and contribute relevant organ donor data via a shared web-portal. Through this active participation, a secondary gain will be improved reporting of donor data and compliance with already accepted donor management goals.
Test of feasibility will be improvement in various kidney function metrics that are commonly used to evaluate organ health during the donation process. Ultimately, the investigators believe this multi-pronged approach may lead to 800 to 1000 additional kidneys that are successfully transplanted nationwide each year.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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Hypothermia
The intervention will take place after consent for donation and research has been obtained and hemodynamic stability has been achieved (mean arterial blood pressure \> 60 mmHg for more than one hour without an increase in vasopressors). Organ donors in the experimental group will either be actively warmed or allowed to spontaneously reach a body temperature of 34 °C.
Hypothermia
The intervention will take place after consent for donation and research has been obtained and hemodynamic stability has been achieved (mean arterial blood pressure \> 60 mmHg for more than one hour without an increase in vasopressors). Organ donors in the experimental group will either be actively warmed or allowed to spontaneously reach a body temperature of 34 °C.
Standard Treatment
No interventions assigned to this group
Interventions
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Hypothermia
The intervention will take place after consent for donation and research has been obtained and hemodynamic stability has been achieved (mean arterial blood pressure \> 60 mmHg for more than one hour without an increase in vasopressors). Organ donors in the experimental group will either be actively warmed or allowed to spontaneously reach a body temperature of 34 °C.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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California Transplant Donor Network
NETWORK
University of California, San Francisco
OTHER
Responsible Party
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Claus Niemann
Professor of Anesthesia & Surgery
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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References
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Malinoski D, Patel MS, Axelrod DA, Broglio K, Lewis RJ, Groat T, Niemann CU. Therapeutic Hypothermia in Organ Donors: Follow-up and Safety Analysis. Transplantation. 2019 Nov;103(11):e365-e368. doi: 10.1097/TP.0000000000002890.
Axelrod DA, Malinoski D, Patel MS, Broglio K, Lewis R, Groat T, Lentine KL, Schnitzler M, Niemann CU. Modeling the economic benefit of targeted mild hypothermia in deceased donor kidney transplantation. Clin Transplant. 2019 Jul;33(7):e13626. doi: 10.1111/ctr.13626.
Niemann CU, Feiner J, Swain S, Bunting S, Friedman M, Crutchfield M, Broglio K, Hirose R, Roberts JP, Malinoski D. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med. 2015 Jul 30;373(5):405-14. doi: 10.1056/NEJMoa1501969.
Other Identifiers
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R38OT22183
Identifier Type: -
Identifier Source: org_study_id